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CompletedNCT00002218Updated Jun 24, 2005

A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients

A Phase 1 interventional study of CI-1012 in HIV Infections, sponsored by Parke-Davis. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Parke-Davis · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.

Read the detailed description

Doses are escalated based on safety assessments: As soon as a dose meets the criteria for "tolerated" or "not tolerated", doses are escalated or terminated, respectively. All patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.

02

Conditions studied

  • HIV Infections

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Keywords

  • HIV-1
  • Dose-Response Relationship, Drug
  • Anti-HIV Agents
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 40 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Parke-Davis is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients must have:

  • Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot).
  • CD4 T cell count less than or equal to 200 mm3.
  • HIV-1 RNA greater than or equal to 5,000 copies/mL.

Exclusion criteria

Exclusion Criteria

Prior Medication:

Excluded:

  • Anti-HIV treatment within 8 weeks prior to entry.
  • Systemic steroids within 4 weeks prior to entry.

Prior Treatment:

Excluded:

Treatment with anticancer agents within 4 weeks prior to study.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrollment
40 participants

Interventions

  • DrugCI-1012
06

Study locations

6 sites
  • ViRx Inc
    Palm Springs, California 92262, United States
  • ViRx Inc
    San Francisco, California 94109, United States
  • Central Florida Research Initiative
    Maitland, Florida 32751, United States
  • Natl Institutes of Health
    Bethesda, Maryland 20892, United States
  • Univ of Michigan
    Ann Arbor, Michigan 48109, United States
  • Univ of Utah Med School / Clinical Trials Ctr
    Salt Lake City, Utah 84108, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002218
Lead sponsor
Parke-Davis
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 1998. You cannot join it, but the record below documents what was studied.

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